Director Of Regulatory Affairs Jobs in Massachusetts

Job Title: Director, Regulatory Affairs Company: Volcano Corporation Location: Billerica, MA Description: Volcano Corporation provides rewarding and challenging employment opportunities for those qualified and selected individuals wishing to join us as we develop, market, and manufacture products that improve the overall quality of medical care. Come join Volcano Corporation - a team leading the way! To develop and execute product approval regulatory strategies for product development teams. Ensure compliance with all applicable domestic and international standards and regulations that pertain to regulatory approval and maintenance on the market; interpreting regulations and guidelines; prepare and execute regulatory plans; represent the Regulatory Affairs department and provide guidance while participating on cross functional medical development teams. Develop, review and approve product labeling and literature, advertising and promotional materials. Ensure that overall regulatory activities are conducted and documented in accordance with US FDA requirements and guidelines, applicable international requirements and guidelines, and company procedures. Responsibilities: Develop strategies for product submissions/registrations in accordance with current worldwide regulations and guidelines. Reviews and approves product release status for new products. Prepare and oversee as necessary the preparation of all FDA submissions; 510K’s, IDE’s, PMA’s, etc. Prepare and oversee as necessary the preparation of all European registrations for new or modified products; CE marking, design/technical dossiers, etc. Prepare and oversee as necessary the preparation of Japanese product submissions. Maintains technical reports & certifications from all regulatory agencies. Oversee various compliance activities / processes as needed including employee training on regulatory topics. Develop and manage process for advertising and promotion product claims made, assist with developing/sourcing supportive documentation for the review and approval of labeling decisions, documents, advertising and promotional literature; some of which may be used as part of the marketing application to regulatory authorities.; insure conformity and compliance with approved claims. Education: Bachelor’s degree in Health Sciences, Biomedical engineering or related field required. Master’s degree desirable. Knowledge and Experience: A minimum of fifteen (15) years in the regulatory affairs field, four to six (4-6) of these years must be experience at a manager-level. Medical device experience a must; US 510K and PMA submissions European CE marking experience. Class III design dossier and Class IIa/IIb Technical File Japanese MHLW/Shonin regulatory process. Additional Desirable Qualifications: Regulatory Affairs Certification (RAC). Skills and Abilities: Well-developed organizational skills required Advanced written and verbal communication skills Previous practical experience in regulatory activities in cardiovascular medical device applications highly desirable Proficiency in Microsoft Office Suite, particularly Word and Excel Personnel management Project management. Problem Solving and Decision Making: Assessing an appropriate regulatory path based upon global business strategies. Regulatory solutions taking financial responsibility into account Regulatory solutions with consideration and guidance relative to impacts to operations and manufacturing. Physical Requirements: Ability to hear and speak to employees and outside business associates on the phone and in person Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) Requires moderate right and left hand coordination for the use of the personal computer. Supervisory Responsibility: RA Associate RA Assistant Project TeamsTravel Requirements: International travel to Japan and Europe at least quarterly US travel as necessary for meetings, seminars, training and conferences. We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.Microsoft Office

Job Title: Director Regulatory Affairs Company: Sanofi-Aventis Pharmaceuticals Location: Cambridge, MA Description: The Director of Regulatory Affairs provides direct regulatory support for multiple diagnostic projects within in the Novartis Molecular Diagnostic unit. Develops and implements regulatory strategy for both companion diagnostics and standalone diagnostics. Lead program efforts relative to premarket submission, diagnostic partnering, FDA interface regulatory policy and practice. Facilitate integration of Dx regulatory strategy within the Drug/Diagnostic Co-development initiatives at Novartis. Self directed position with limited oversight for most assignments. Major Accountabilities (Describe the main results of the job to be achieved )• Ensure early diagnostic regulatory input around Proof of Concept and during clinical development to Technical and Clinical Development Teams for all diagnostic tests applicable to the Drug Development programs• Implement the Regulatory Affairs vision for regulatory affairs for molecular diagnostics and the action roadmap for activities with the regulatory bodies beyond the actual programs to ensure Novartis’ interests are reflected• Collaborate closely with drug regulatory affairs for all companion diagnostic programs• Provide input for all BD&L and M&A activities with respect to the regulatory risks and benefits of potential deals• Provide training for key stakeholders internal and external of MDx (e.g. DRA in pharma)• Represents the Diagnostic regulatory team internally and externally with objective advocacy of the projects pipeline potential as well as the overall regulatory perspective in diagnostic regu-latoryKey Performance Indicators (Indicate how performance will be measured: indicators, activities…) ? Complete and timely submission of regulatory documents to authorities ? Successful negotiations of Novartis interests with regulatory bodies? Successfully broaden the regulatory knowledge within the MDx Leadership Team and Novartis Pharma? Standardized MDx regulatory policies and practices

Job Title: Regulatory Affairs Manager - Medical Device CRO - Boston Company: CyberCoders Location: Boston, MA Description: Regulatory Affairs Manager - Medical Device CRO - BostonWe specialize in expertly assisting medical device companies, drug/device biologic companies and pharmaceutical product manufacturers meet the clinical, quality, safety, and regulatory requirements of the product development process. We are an international full-service clinical CRO and provide clinical, regulatory, and data management services for medical device and pharmaceutical trials. Responsibilities: * Regulatory strategy planning for new medical device products. * Reviewing documentation provided by clients, preparing a gap analysis and writing or supervising the writing of documentation to fill those gaps for domestic 510(k) applications and PMAs and CE mark applications internationally. * Reviewing documentation provided by clients, preparing a gap analysis and writing or supervising the writing of documentation to fill those gaps for clinical trial applications as part of IDE's domestically and internationally. * Preparing 510(k), PMA, IDE, CE Mark applications and CTAs for clients. * Leading interactions with the FDA, health authorities, and Notified Bodies on behalf of clients. * Occasional Regulatory strategy planning for pharmaceutical products * Reviewing documentation provided by clients, preparing a gap analysis and writing or supervising the writing of documentation to fill those gaps for IND applications to the FDA and CTA (IMPD) applications internationally. * Ability to manage regulatory projects from regulatory strategy to submission taking into consideration all regulatory requirements, client expectations and project timelines. * Position will be based in Boston with travel throughout the US and internationally. Qualifications: * Bachelor's Degree in the Science field * 5+ years' experience as a regulatory professional in the medical devices and or pharmaceutical industry (at a pharmaceutical and or device manufacturer, notified body or regulatory agency); previous work in a contract research organization environment would be advantageous * Expert knowledge of medical device regulations in the US and internationally.* Expert knowledge of pharmaceutical regulations in the US and internationally.* Good understanding of clinical research, device/drug development, and good clinical research practices and statistical methods. * Good understanding of clinical research drug development, good clinical practices and statistical methods would be advantageous.* Competent word processing (Word), spreadsheet (Excel) and presentation (Powerpoint) skills * Excellent spoken and written English; oral competence in a second language such as German, French or Spanish would be useful * Excellent interpersonal skills with the ability to communicate effectively with scientific and non-scientific groups; strong organizational skills with good attention to detail * Strong sense of responsibility, urgency and integrity and ability to work flexibly to meet changing scopes and timelinesMust be authorized to work in the United States on a full-time basis for any employer.

Job Title: Senior Director of Regulatory Affairs Company: Clinical Staffing, Inc. Location: Cambridge, MA Description: Sr. Director/Director of Regulatory Affairs About Us Clinical Staffing Inc. is a national Pharmaceutical recruiting firm that focuses on Clinical Personnel such as CRA's,Data Management, Regulatory Affairs and Quality Assurance. Our clients are Pharmaceutical, Biotech and CRO companies. We cover all over the US with majority of the jobs located in NJ,PA,California and Mass. areas. We work with small to Fortune 500 companies Responsible for managing the personnel and activities of New Products group within Regulatory Affairs, including developing, implementing and maintaining regulatory strategies and submissions during new product development and approval processes and maintaining a positive corporate regulatory posture. This position serves as an internal regulatory consultant to interpret regulations and guidances, particularly regarding IND and NDA submissions and corresponding FDA interactions. This position oversees the writing and compiling of FDA submissions for new product approvals, as well as coordinating international submissions to support corresponding development activities. This position also oversees the Regulatory Affairs representatives and responsibilities e Requirements: -Advanced Degree -5-8 years of Regulatory Affairs Experience Send resumes to Register to View or Call Jesse Gill Recruiter Clinical Staffing Inc. Register to View Register to View

Job Title: Associate Director/Director of Regulatory Affairs Advertising and Promotional Review Company: MRINetwork Location: Boston, MA Description: Associate Director/Director of Regulatory Affairs Advertising and Promotional ReviewOur client, located in the Philadelphia, PA area, is a biotech organization focusing on drug discovery and development in the areas of oncology and inflammation.  They are experiencing significant growth and looking to add key members to the organization.  If you are a regulatory advertising and promotional professional looking for your next challenge, this could be the place for you. Job Responsibilities:Establish and manage the advertising and promotional functions within the organization Responsible for directing post-marketing regulatory activities.Interact with DDMAC routinely and regulatory agencies on post-marketing subject matter.Provide regulatory, operational, and management expertise for post-marketing activities. Knowledge of pre-marketing regulations and able to provide support on ongoing pharmaceutical development programs.Assist in the marketing of regulatory strategy and manages the regulatory aspects of the program and people contributing to the program. Provide regulatory oversight in the development, review, and approval of presentations and materials to be used by medical liaisons and other scientific staff.Responsible for professional development of regulatory staff.Job Requirements:B.S./M.S. in Life Science (PharmD preferred) with a minimum of five to eight (5-8) years regulatory affairs experience.Prior regulatory experience with US labeling, promotion and advertising      reviews, strategy for marketed products, and interaction with DDMAC required. In depth understanding of regulatory processes, procedures, guidelines and regulationsMust be able to function as the regulatory expert on post-marketing, advertising and promotionGood understanding of the drug development processExperienced in presenting information at internal and external meetings.Compensation: $157,000.00 (compensation commensurate with experience and salary history). Annual target bonus, stock options, comprehensive benefits package and relocation assistance.For confidential consideration, please forward your resume in a Word document to: mailto: Register to View   only qualified candidates will be contacted. Visit www.kleinhersh.com to view other job opportunities available through our company.

Job Title: Regulatory Affairs Manager Company: The River Group Inc Location: Boston, MA Description: Job Title: Manager of Regulatory Affairs (RM22-10) Reports To: Director, Regulatory Affairs Location: Boston, MA Area (LOCAL CANDIDATES ONLY) Compensation: $95,000 - $110,000 Benefits: Excellent benefits, including medical and dental coverage, flexible spending program; tuition reimbursement and 401(k) with employer match About our Client: A leader in the development, manufacture and distribution of medical devices sold in more than 67 countries worldwide. Key Responsibilities: • This is an exciting opportunity for a Regulatory Affairs Manager to provide regulatory guidance and oversight while updating the Leadership Team on new and evolving regulatory developments and competitive product approvals. • As the leader for all aspects of assuring regulatory approvals, you will guide the company in developing and implementing practices which meet regulatory requirements both in the USA and internationally. Job Requirements: • BS or BA degree in technical discipline or equivalent related work experience with a minimum of 7 years experience in the medical device, biologic, or pharmaceutical fields. • Minimum of 4 years experience in medical device regulatory affairs. • Must have demonstrated success in regulatory submissions along with current knowledge of U.S. medical device regulations and ISO Quality Sytem. • RAPS Certification (RAC) strong preferred.                                                       About The River Group - Resumes presented to The River Group are never submitted to a client company unless the candidate authorizes the submission of the resume and agrees to become a candidate for the position. - After your resume is submitted to the company you will be assisted in every way possible throughout the recruiting process, including preparation for the telephone and personal interview, gathering references, evaluating offers, and managing the negotiations.

Job Title: Manager Regulatory Affairs Company: The Cambridge Group Ltd. Location: Berlin, MA Description: Manager Regulatory AffairsThe Manager Regulatory Affairs is responsible for multiple product lines, technologies and specialized functions.  The incumbent will devote a significant portion of time to managerial, leadership and employee development responsibilities.  Direct and coordinate activities of Regulatory Affairs employees, including direct supervision of related team.  Provide day to day management of Regulatory Affairs function for major divisional business segment.  Establish project priorities, allocating resources and workload.  Provide technical guidance to team during the course of strategy formulation, submission preparation and interaction with regulatory bodies.  Review and edit submissions prepared by staff.  Represent Regulatory Affairs at management updates.  Provide long range strategy formulation.  Develop and implement departmental policy and procedures.  Provide Regulatory Affairs training/mentoring to other employees.  Support and maintain quality initiatives in accordance with BSC Quality Policy.  Continuously assess ways to improve quality.  Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.  Develop and implement regulatory strategies for new and modified products.  Oversee preparation and submission of global regulatory applications as well as internal regulatory file documentation.  Oversee review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.  Review and signs-off on product and manufacturing changes for compliance with applicable regulations.  Support highly technical or major business segment product lines, special projects and strategic initiatives.  A bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline is required.  Professional certification(s) preferred.  9 plus years Regulatory Affairs medical industry experience preferred. 5 plus years managerial/supervisory experience preferred.  Overall understanding of global regulations.  Strong technical knowledge of medical products. Comprehensive understanding of relevant medical procedures, practices, terminology, and products.  Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.  Thorough knowledge of product development process and design control.  Excellent research and analytical skills.  Excellent written and oral communication, technical writing and editing skills.  Ability to effectively manage multiple projects.  Strong organizational, leadership, interpersonal and influencing skills.  Proficiency with Microsoft Office.Please refer to job code SD6808 when responding to this ad.